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Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate (LIMPER-DRF)

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ClinicalTrials.gov Identifier: NCT05150925
Recruitment Status : Recruiting
First Posted : December 9, 2021
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Aleksi Reito, Tampere University Hospital

Study Description
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Brief Summary:
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Other: Cast treatment Other: Immediate mobilization Procedure: Volar plating Not Applicable

Detailed Description:
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Immediate mobilization after distal radius fracture treated with volar locking plate Other: Immediate mobilization
Immediate mobilization postoperatively without casting

Procedure: Volar plating
Volar plating of distal radius fracture
Active Comparator: 2 weeks cast immobilization after distal radius fracture treated with volar locking plate Other: Cast treatment
Dorsal cast placed in OR

Procedure: Volar plating
Volar plating of distal radius fracture


Outcome Measures
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Primary Outcome Measures :
  1. Patient-rated wrist evaluation questionnaire [ Time Frame: 2 months ]
    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  2. Total lenght of the sick leave [ Time Frame: 12 months ]
    Total number of days of work during the 1 year study period


Secondary Outcome Measures :
  1. Patient-rated wrist evaluation questionnaire [ Time Frame: 4 weeks ]
    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  2. Patient-rated wrist evaluation questionnaire [ Time Frame: 6 months ]
    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  3. Patient-rated wrist evaluation questionnaire [ Time Frame: 12 months ]
    The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.

  4. Return to work [ Time Frame: 4 weeks ]
    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  5. Return to work [ Time Frame: 2 months ]
    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  6. Return to work [ Time Frame: 6 months ]
    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  7. Return to work [ Time Frame: 12 months ]
    Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.

  8. Complications [ Time Frame: 4 weeks ]
    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  9. Complications [ Time Frame: 2 months ]
    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  10. Complications [ Time Frame: 6 months ]
    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  11. Complications [ Time Frame: 12 months ]
    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

  12. Self-perceived working ability [ Time Frame: 4 weeks ]
    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  13. Self-perceived working ability [ Time Frame: 2 months ]
    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  14. Self-perceived working ability [ Time Frame: 6 months ]
    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  15. Self-perceived working ability [ Time Frame: 12 months ]
    Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).

  16. Visual analogue pain scale [ Time Frame: 4 weeks ]
    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  17. Visual analogue pain scale [ Time Frame: 2 months ]
    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  18. Visual analogue pain scale [ Time Frame: 6 months ]
    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  19. Visual analogue pain scale [ Time Frame: 12 months ]
    Overall pain during last 7 days in a scale from 0 to 100 (worst)

  20. Patient-acceptable symptom state [ Time Frame: 2 months ]
    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  21. Patient-acceptable symptom state [ Time Frame: 6 months ]
    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  22. Patient-acceptable symptom state [ Time Frame: 12 months ]
    Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?

  23. Work capacity [ Time Frame: 4 weeks ]
    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  24. Work capacity [ Time Frame: 2 months ]
    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  25. Work capacity [ Time Frame: 6 months ]
    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.

  26. Work capacity [ Time Frame: 12 months ]
    The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.


Other Outcome Measures:
  1. Patient activity [ Time Frame: 4 weeks ]
    Patient activity measured with triaxial wrist accelerometer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intra- or extra articular DRF (Colles, Smith, Volar barton)
  • operative treatment justified

Exclusion Criteria:

  • Refusal to participate in the study
  • Open fracture with a severity greater than Gustilo grade 1
  • Patient aged less than 18 or over 65
  • Patient does not understand written or spoken guidance in local languages
  • Pathological fracture
  • Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
  • Ipsilateral fracture in upper extremity
  • Associated fractures of the ulna (except fractures of the PSU)
  • Polytrauma
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05150925


Contacts
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Contact: Laura Kärnä, MD +3583311611 laura.karna@pshp.fi
Contact: Antti Launonen +3583311611 antti.launonen@pshp.fi

Locations
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Finland
Teemu Karjalainen Recruiting
Jyväskylä, Finland
Contact: Ville Ponkilainen         
Contact: Toni Luokkala         
Laura Kärnä Recruiting
Tampere, Finland
Contact: Laura Kärnä    +3583311611      
Principal Investigator: Reito         
Sub-Investigator: Launonen         
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Director: Aleksi Reito Tampere University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aleksi Reito, Associate professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT05150925    
Other Study ID Numbers: R21111
First Posted: December 9, 2021    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is available on reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After the study has been completed and for 10 years after.
Access Criteria: On reasonable request and research plan for IPD use should be provided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleksi Reito, Tampere University Hospital:
distal radius fracture
volar plating
surgery
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wrist Fractures
Wounds and Injuries
 Forearm Injuries
Arm Injuries
Wrist Injuries